FOIAengine: Multiple Hedge Funds Seeking Inspection Reports
Leading medical device manufacturer Insulet Corporation’s stock price (NASDAQ: PODD) is on a roll. But that hasn’t stopped leading financial firms from monitoring the company’s Food and Drug Administration plant inspections to learn of any bad news that might slow its growth.
During April, Wall Street analysts characterized Insulet as “revolutionizing,” “a top performer,” and a “solid wealth creator.” On May 9, a Barrons’ headline said “Insulet Stock Is the Top S&P 500 Performer Today.” On May 26, a research firm noted that “its stock price has risen 78.5 percent over the past year at a time when the device industry experienced 7.3 percent growth.”
And full-year 2025 earnings forecasts call for a 30 percent rise, followed by a 24 percent increase in 2026.
Insulet was founded in 2000 to improve the delivery of insulin to those with diabetes. Years of innovation have led to its current model, the Omnipod 5 Automated Insulin Delivery System, which is approved by the FDA for people with Type 1 diabetes ages 2 years and older and Type 2 diabetes ages 18 years and older. Competing products are offered by Tandem Diabetes Care and Medtronic. Still, Wolfe Research believes Insulet could reach a market share of 40 to 50 percent.
But these positive signs don’t stop investment firms from using the Freedom of Information Act to find clues about future market shifts by using one of the financial industry’s favorite FOIA tools — FDA Form 483 plant inspection reports. These reports are not publicly available, but companies and individuals may request copies of the reports by submitting FOIA requests to the FDA.
According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, fully 33 percent of the 1,054 FOIA requests submitted to the agency in April included a request for one or more Form 483 reports.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act. Observations noted on the form must be “clear, specific and significant” and are made “when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”
During April, the FDA received five FOIA requests seeking Form 483 reports about inspections of Insulet plants.
Three of those were from investment firms – Point72, Tamridge Capital LLC, and ExodusPoint.
- Alternative Investment firm Point72 submitted a request on April 25 seeking “copies of any agency documentation or communication regarding the Form 483 (FEI 3014585508) issued to Insulet Corporation at 50 & 100 Nagog Park, Acton, MA 01720 from January 1st, 2025-Present.”
- San Francisco-based investment firm Tamridge Capital LLC submitted a request on April 15 seeking “copies of the all the 483 inspection reports, and any subsequent related correspondence for the facility inspection listed below: Firm Name: Insulet Corporation Program Type: Devices FEI Number: 3014585508 Firm Address: 50 & 100 Nagog Park, Acton, MA 01720 Inspection Date: 3/31/2025.”
- Investment firm ExodusPoint submitted a request on April 25, asking for “form 483 inspection materials for the inspection conducted on 03/31/2025 for Insulet Corporation, located at Acton, MA.”
Two addition FOIA requests for Insulet plant inspection reports were submitted by commercial research firms.
- Life sciences services firm Redica Systems submitted on April 30 a request seeking “The 483 (in electronic format) for the Medical Devices inspection of Insulet Corporation, located at 50 & 100 Nagog Park, Acton, MA, 01720-3440, United States, inspection ending 3/31/2025 (FEI 3014585508).”
- Global data services firm Clarivate Analytics (France) submitted on April 30 a request seeking “Form FDA 483: Insulet Corporation. Acton, Massachusetts, United States Dates of inspection: 31 Mar 2025 Project Area: Compliance: Devices FEI: 3014585508 Classification: VAI.”
Time will tell whether these reports include bad news for Insulet. Negative observations identified in Form 483 reports can move a company’s stock price. Financial industry 483 requests to the FDA often target vulnerable companies. In the case of Insulet, the requesters either may have heard something, or may want to anticipate whether the rising price of the company’s stock price could be affected by bad news.
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities, and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
To see all the requests mentioned in this article, log in or sign up to become a FOIAengine user.
Next: The latest hedge fund and media requests to the SEC and FTC.
Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Learn more about FOIAengine here. Sign up here to become a trial user of FOIAengine.
Write to Randy E. Miller at randy@poliscio.com.
